Tirzepatide once weekly for the treatment of obesity in people with type 2 diabetes (SURMOUNT-2): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial
Open accessAbstract
BACKGROUND Weight reduction is essential for improving health outcomes in people with obesity and type 2 diabetes. We assessed the efficacy and safety of tirzepatide, a glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist, versus placebo, for weight management in people living with obesity and type 2 diabetes. METHODS This phase 3, double-blind, randomised, placebo-controlled trial was conducted in seven countries. Adults (aged ≥18 years) with a body-mass index (BMI) of 27 kg/m2 or higher and glycated haemoglobin (HbA1c) of 7-10% (53-86 mmol/mol) were randomly assigned (1:1:1), using a computer-generated random sequence via a validated interactive web-response system, to receive either once-weekly, subcutaneous tirzepatide (10 mg or 15 mg) or placebo for 72 weeks. All participants, investigators, and the sponsor were masked to treatment assignment. Coprimary endpoints were the percent change in bodyweight from baseline and bodyweight reduction of 5% or higher. The treatment-regimen estimand assessed effects regardless of treatment discontinuation or initiation of antihyperglycaemic rescue therapy. Efficacy and safety endpoints were analysed with data from all randomly assigned participants (intention-to-treat population). This trial is registered with ClinicalTrials.gov, NCT04657003. FINDINGS Between March 29, 2021, and April 10, 2023, of 1514 adults assessed for eligibility, 938 (mean age 54·2 years [SD 10·6], 476 [51%] were female, 710 [76%] were White, and 561 [60%] were Hispanic or Latino) were randomly assigned and received at least one dose of tirzepatide 10 mg (n=312), tirzepatide 15 mg (n=311), or placebo (n=315). Baseline mean bodyweight was 100·7 kg (SD 21·1), BMI 36·1 kg/m2 (SD 6·6), and HbA1c 8·02% (SD 0·89; 64·1 mmol/mol [SD 9·7]). Least-squares mean change in bodyweight at week 72 with tirzepatide 10 mg and 15 mg was -12·8% (SE 0·6) and -14·7% (0·5), respectively, and -3·2% (0·5) with placebo, resulting in estimated treatment differences versus placebo of -9·6% percentage points (95% CI -11·1 to -8·1) with tirzepatide 10 mg and -11·6% percentage points (-13·0 to -10·1) with tirzepatide 15 mg (all p<0·0001). More participants treated with tirzepatide versus placebo met bodyweight reduction thresholds of 5% or higher (79-83% vs 32%). The most frequent adverse events with tirzepatide were gastrointestinal-related, including nausea, diarrhoea, and vomiting and were mostly mild to moderate in severity, with few events leading to treatment discontinuation (<5%). Serious adverse events were reported by 68 (7%) participants overall and two deaths occurred in the tirzepatide 10 mg group, but deaths were not considered to be related to the study treatment by the investigator. INTERPRETATION In this 72-week trial in adults living with obesity and type 2 diabetes, once-weekly tirzepatide 10 mg and 15 mg provided substantial and clinically meaningful reduction in bodyweight, with a safety profile that was similar to other incretin-based therapies for weight management. FUNDING Eli Lilly and Company.
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Recently, several large-scale randomized controlled trials specifically targeting patients with obesity but without diabetes have been published.
“Recently, several large-scale randomized controlled trials (RCTs) specifically targeting patients with obesity but without diabetes have been published [24,25,26,27,28].”
From The Efficacy and Safety of Tirzepatide in Patients with Diabetes and/or Obesity: Systematic Review and Meta-Analysis of Randomized Clinical Trials (2025) · cites this paper as [26]
The Trial design and participants section (page unavailable) says participants were required to have type 2 diabetes. The Participants section reports 938 people were randomized. Although this is a large randomized trial of obesity treatment, it contradicts the cited sentence’s defining qualifier, “without diabetes.” (LLM, conf=0.94)
Checked by a reasoning model — may be wrong.
Experimental — accuracy not yet measuredTirzepatide produced a 15.7% reduction in body weight in patients with obesity and diabetes.
“and a 15.7% reduction in body weight in patients with obesity and diabetes [92].”
From Dual and Triple Incretin-Based Co-agonists: Novel Therapeutics for Obesity and Diabetes (2024) · cites this paper as [92]
The Added value of this study section reports weight reductions after 72 weeks in adults with elevated BMI and type 2 diabetes, supporting the direction of the claim. It gives 12.8% for tirzepatide 10 mg and 14.7% for 15 mg, however, not the claimed 15.7%; the Discussion likewise describes a mean reduction of up to 14.7%. The supplied passages do not provide page numbers. (LLM, conf=0.88)
Experimental — accuracy not yet measuredIn SURMOUNT-1 and SURMOUNT-2, improvements in weight were associated with improved quality of life parameters, physical function and cardiometabolic risk factors.
“In both studies, improvements in weight associated with improved quality of life parameters, physical function and cardiometabolic risk factors [47].”
From What is the pipeline for future medications for obesity? (2025) · cites this paper as [47]
The Discussion (page unavailable) explicitly says that weight reduction in SURMOUNT-2 was accompanied by improvements in health-related quality of life, physical function, and cardiometabolic risk factors. The Introduction (page unavailable) reports associated improvements in cardiometabolic risk factors and patient-reported outcomes in SURMOUNT-1, but does not specify that its quality-of-life or physical-function measures improved. (LLM, conf=0.84)
Experimental — accuracy not yet measuredIn SURMOUNT-2, mean weight loss was up to 15.7% with tirzepatide 15 mg compared to 3.3% with placebo at 72 weeks for people with obesity and T2D.
“In SURMOUNT-2, the mean WL was up to 15.7% with tirzepatide 15 mg compared to 3.3% WL with placebo at 72 weeks for people with obesity and T2D [47].”
From What is the pipeline for future medications for obesity? (2025) · cites this paper as [47]
The Discussion reports substantial mean weight loss after 72 weeks in adults with elevated BMI and type 2 diabetes, including 14.7% with tirzepatide 15 mg. It does not support the cited 15.7% figure, and the retrieved weight-loss passages do not establish 3.3% for placebo. (LLM, conf=0.86)
Experimental — accuracy not yet measuredThe SURMOUNT Program includes four global phase 3, randomized, placebo-controlled clinical trials with tirzepatide administered subcutaneously once weekly in conjunction with lifestyle intervention.
“The SURMOUNT Program includes four global phase 3, randomized, placebo-controlled clinical trials with tirzepatide administered subcutaneously once weekly in conjunction with lifestyle intervention.47, 48, 49”
From GLP-1 single, dual, and triple receptor agonists for treating type 2 diabetes and obesity: a narrative review (2024) · cites this paper as [48]
The Trial design and participants and Procedures sections describe SURMOUNT-2 as a multinational, phase 3, randomized, placebo-controlled trial using once-weekly subcutaneous tirzepatide alongside lifestyle intervention. The cited paper does not establish that all four SURMOUNT trials had those features; searches for a four-trial program description did not find one in our copy. Page numbers were not available. (LLM, conf=0.86)
Experimental — accuracy not yet measured
There was a substantial degree of weight reduction with 10 mg and 15 mg doses of tirzepatide of 18.4-20.9% in persons with obesity or preobesity (without diabetes), with improvements in cardiometabolic risk factors.
“There was a substantial degree of weight reduction with 10 mg and 15 mg doses of 18.4–20.9% in persons with obesity or preobesity (without diabetes), with improvements in cardiometabolic risk factors (Table 2).47, 48, 49”
From GLP-1 single, dual, and triple receptor agonists for treating type 2 diabetes and obesity: a narrative review (2024) · cites this paper as [48]
The Discussion reports 19.5% and 20.9% weight reduction with the 10 mg and 15 mg doses in participants without type 2 diabetes, not the claimed 18.4–20.9% range. The Introduction also reports associated cardiometabolic improvements. SURMOUNT-2 itself studied people with type 2 diabetes and found smaller reductions of 12.8% and 14.7%. (LLM, conf=0.88)
Experimental — accuracy not yet measuredIn phase 3 trials, women aged 65 years and older achieved sustained weight loss of 10-20%, with consistent cardiometabolic improvements.
“In phase 3 trials, women aged ≥ 65 years achieved sustained weight loss of 10–20%, with consistent cardiometabolic improvements.”
From A Narrative Review on GLP-1 Receptor Agonists for Obesity in Older Women: Maximizing Weight Loss While Preserving Lean Mass (2026) · cites this paper as [41]
The Participants and Discussion sections report 12.8% and 14.7% mean weight loss at week 72 in the overall SURMOUNT-2 trial population, and the Cardiometabolic risk factors section reports improvements versus placebo (page numbers unavailable). The copy does not establish those results specifically for women aged 65 or older; it also reports one phase 3 trial, not multiple trials. (LLM, conf=0.88)
Experimental — accuracy not yet measuredThe STEP program for semaglutide and the SURMOUNT trials for tirzepatide offer critical insights into the benefits of these therapies in older populations.
“Two major trial programs, the STEP program for semaglutide [35,36,37,38,39] and the SURMOUNT trials [40,41,42,43] for tirzepatide, offer critical insights into the benefits of these therapies in older populations.”
From A Narrative Review on GLP-1 Receptor Agonists for Obesity in Older Women: Maximizing Weight Loss While Preserving Lean Mass (2026) · cites this paper as [41]
SURMOUNT-2 is a tirzepatide trial, and Table 1 reports that 165 participants (17.6%) were aged 65 or older. The Results report benefits for participants overall, but do not establish those benefits specifically for the older subgroup. This source does not itself test semaglutide in the STEP program. (LLM, conf=0.85)
Experimental — accuracy not yet measuredIn the SURMOUNT trials, participants showed improvements in insulin sensitivity, greater reductions in fat mass, and modest improvements in physical functioning metrics such as mobility and endurance.
“In addition to weight loss, participants in these trials showed improvements in insulin sensitivity, greater reductions in fat mass, and modest improvements in physical functioning metrics, such as mobility and endurance.”
From A Narrative Review on GLP-1 Receptor Agonists for Obesity in Older Women: Maximizing Weight Loss While Preserving Lean Mass (2026) · cites this paper as [41]
The Results (indexed as “Other Exclusions,” page unavailable) report greater improvements in physical-function questionnaire scores with tirzepatide than with placebo. The paper also reports improved fasting glucose and insulin, but does not establish improved insulin sensitivity; the passages do not report fat-mass reductions or separate mobility and endurance outcomes. (LLM, conf=0.86)
Experimental — accuracy not yet measuredTirzepatide produced mean body weight reductions ranging from 15% to 21% in the SURMOUNT-1 and SURMOUNT-2 trials.
“Similarly, the SURMOUNT-1 [40] and 2 [41] trials, which evaluated the effects of tirzepatide, revealed even greater weight loss efficacy, with mean reductions in body weight ranging from 15% to 21%.”
From A Narrative Review on GLP-1 Receptor Agonists for Obesity in Older Women: Maximizing Weight Loss While Preserving Lean Mass (2026) · cites this paper as [41]
The Discussion reports mean weight reductions of 12.8% and 14.7% in SURMOUNT-2, alongside 19.5% and 20.9% in SURMOUNT-1. Although 14.7% and 20.9% round to about 15% and 21%, the stated range omits SURMOUNT-2’s 12.8% result. (LLM, conf=0.90)
Experimental — accuracy not yet measuredOverall findings from the SURMOUNT trials support the efficacy of tirzepatide in older women, particularly those with obesity and type 2 diabetes.
“While the data on women over 75 years of age remains limited, the overall findings from these trials support the efficacy of tirzepatide in older women, particularly those with obesity and type 2 diabetes, a common comorbidity in this population [Table 1].”
From A Narrative Review on GLP-1 Receptor Agonists for Obesity in Older Women: Maximizing Weight Loss While Preserving Lean Mass (2026) · cites this paper as [41]
The Implications section reports substantial weight reduction and improved HbA1c in adults with obesity and type 2 diabetes. Table 1 shows that 17.6% of participants were at least 65 and 50.7% were female, but the paper does not report efficacy specifically for older women or women over 75. The claim extends the overall trial result to a subgroup not separately established here; no page numbers are available in our copy. (LLM, conf=0.87)
Experimental — accuracy not yet measuredMore than 70% of patients in clinical trials of GLP-1 receptor agonists reported adverse events, most often gastrointestinal, that were mild.
“More than 70% of patients in clinical trials of GLP-1 RAs reported adverse events, most often gastrointestinal (GI), that were mild.3,4,5,6,7”
From Discontinuation and Reinitiation of Dual-Labeled GLP-1 Receptor Agonists Among US Adults With Overweight or Obesity (2025) · cites this paper as [4]
The Safety section (page not specified) reports adverse events in 77.6% and 71.4% of the two tirzepatide groups, with gastrointestinal events most frequent. It describes those events as mostly mild to moderate, not simply mild. This single trial of tirzepatide, a dual GIP/GLP-1 receptor agonist, does not establish the claim across clinical trials of GLP-1 receptor agonists. (LLM, conf=0.86)
Experimental — accuracy not yet measuredMost patients taking a GLP-1 receptor agonist achieve clinically meaningful weight loss.
“Although most patients taking a GLP-1 RA achieve clinically meaningful weight loss, heterogeneity in response exists.3,4,5,6,7,12”
From Discontinuation and Reinitiation of Dual-Labeled GLP-1 Receptor Agonists Among US Adults With Overweight or Obesity (2025) · cites this paper as [4]
The Results (Participants section; page unavailable) report that 79% and 83% of participants receiving tirzepatide lost at least 5% of their body weight at 72 weeks, supporting the claim for this trial. The paper identifies tirzepatide as a dual GIP and GLP-1 receptor agonist, however, and studied people with obesity and type 2 diabetes; its findings do not establish that most patients taking GLP-1 receptor agonists generally achieve that result. (LLM, conf=0.88)
Experimental — accuracy not yet measuredSURMOUNT 2 found that tirzepatide in people with type 2 diabetes produced a 11.5% placebo-subtracted weight loss at 72 weeks.
“SURMOUNT 2 tested tirzepatide in people with type 2 diabetes, and at 72 weeks found a slightly lower (11.5%)placebo subtracted weight loss.168”
From Effectiveness and safety of drugs for obesity (2024) · cites this paper as [168]
The Discussion reports that adults with type 2 diabetes treated with tirzepatide for 72 weeks lost up to 14.7% of body weight. The passages available from our copy do not establish the claimed 11.5% placebo-subtracted figure, so the specific comparison is not verified. (LLM, conf=0.76)
Experimental — accuracy not yet measuredOf currently available agents, tirzepatide and semaglutide have the highest efficacy in terms of glucose lowering as well as weight loss, followed by dulaglutide, liraglutide, and extended-release exenatide.
“Of the currently available agents, tirzepatide and semaglutide have the highest efficacy in terms of glucose lowering as well as weight loss, followed by dulaglutide, liraglutide, and extendedrelease exenatide (157-161).”
From 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes—2025 (2025) · cites this paper as [157]
The Discussion (page unavailable) reports that tirzepatide produced greater weight loss than reported for semaglutide and liraglutide in trials involving people with obesity and type 2 diabetes. The Results (page unavailable) also report improved HbA1c with tirzepatide versus placebo. The paper does not establish the claimed ranking of all five agents for both glucose lowering and weight loss; in particular, it does not compare dulaglutide or extended-release exenatide. (LLM, conf=0.87)
Experimental — accuracy not yet measuredThese safety findings are similar to those reported for therapies based on GLP-1 or GIP/GLP-1 agonism for the treatment of type 2 diabetes or obesity.
“These safety findings are similar to those reported for therapies based on GLP-1 or GIP/GLP-1 agonism for the treatment of type 2 diabetes or obesity41–45.”
From Triple hormone receptor agonist retatrutide for metabolic dysfunction-associated steatotic liver disease: a randomized phase 2a trial (2024) · cites this paper as [45]
Although no head-to-head trial data exist, phase 2 data suggest that at higher doses retatrutide could lead to greater weight loss compared to the most efficacious approved treatments for obesity and type 2 diabetes such as tirzepatide 15 mg and semaglutide 2.4 mg.
“Although no data from head-to-head trials comparing retatrutide to other currently approved obesity treatments exist, data from the phase 2 studies with retatrutide suggest that at higher doses, retatrutide could lead to greater WL compared to the most efficacious approved treatments for obesity and T2D such as tirzepatide 15 mg and semaglutide 2.4 mg (Fig. 3) [8, 27, 45, 46, 49, 50].”
From Triple Agonism Based Therapies for Obesity (2025) · cites this paper as [50]
In Phase III trials, tirzepatide significantly reduced body weight and improved blood sugar control in adults with T2DM.
“The trials recruited adult participants with T2DM and significantly reduced body weight and improved blood sugar control in these patients.143”
From Glucagon-like peptide-1 receptor: mechanisms and advances in therapy (2024) · cites this paper as [143]
The safety profile of tirzepatide was consistent with that observed in previous trials.
“The safety profile of tirzepatide was consistent with that observed in previous trials. 14,3739”
From Tirzepatide for the Treatment of Obstructive Sleep Apnea and Obesity (2024) · cites this paper as [37]
Lower bodyweight reductions of 12.8% and 14.7% with 10 mg and 15 mg doses of tirzepatide, respectively, were observed in persons with preobesity or obesity and T2DM.
“Lower bodyweight reductions of 12.8% and 14.7% with 10 mg and 15 mg doses of tirzepatide, respectively, were observed in persons with preobesity or obesity and T2DM.48”
From GLP-1 single, dual, and triple receptor agonists for treating type 2 diabetes and obesity: a narrative review (2024) · cites this paper as [48]
The degree of weight loss achieved with tirzepatide 10 and 15 mg in individuals with obesity and type 2 diabetes in SURMOUNT-2 (12.8 and 14.7%) was lower than that observed in SURMOUNT-1 without type 2 diabetes (19.5 and 20.9%).
“Consistent with this, the degree of weight loss achieved with tirzepatide 10 and 15 mg in individuals with obesity and T2D in SURMOUNT-2(12.8 and 14.7%) was lower than that observed in SURMOUNT-1 without T2D (19·5 and 20·9%, respectively) [12, 20].”
The majority of the research analyzed the effectiveness of tirzepatide in treating type 2 diabetes, with body weight alteration as a secondary outcome, except for SURMOUNT-1 and SURMOUNT-2, which primarily tested tirzepatide for obesity treatment.
“The majority of the research analyzed the effectiveness of tirzepatide in treating T2D, with BW alteration as a secondary outcome, except for SURMOUNT-1 [12] and SURMOUNT-2 [20], which primarily tested tirzepatide for the treatment of obesity.”
Seven studies ultimately met all selection criteria and were included in the meta-analysis.
“Seven studies [11, 12, 16–20] ultimately met all selection criteria and were included in the meta-analysis.”
The remaining four studies had low risk in all five domains, indicating an overall low risk of bias for each individual study.
“The evaluation of the remaining four studies [12, 18–20] found them to have low risk in all five domains, indicating an overall low risk of bias for each individual study.”
Preclinical findings are consistent with the results of multiple RCTs evaluating tirzepatide's impact on weight loss and are further supported by the results of this meta-analysis.
“These preclinical findings are consistent with the results of multiple RCTs [11, 12, 16–20] that evaluated the impact of tirzepatide on weight loss, and further supported by the results of our meta-analysis.”
The gastrointestinal adverse events were mostly mild to moderate in severity, temporary, and tolerable; they typically occurred at treatment initiation or during dose-escalation phases, gradually diminished over time, and rarely led to treatment discontinuation.
“However, these GI AEs were mostly mild to moderate in severity, temporary, and tolerable. They typically occurred at treatment initiation or during dose-escalation phases, and gradually diminished over time, rarely leading to treatment discontinuation [12, 18–20].”
GLP-1RAs have been shown to greatly reduce body weight in obese people with type 2 diabetes.
“GLP-1RAs have been shown to greatly reduce the body weight of obese people with type 2 diabetes.8 14”
Weight loss was slightly lower, at 14.7%, in overweight and obese patients with T2DM in the SURMOUNT-2 study.
“Weight loss was slightly lower, at 14.7%, in overweight and obese patients with T2DM in the SURMOUNT-2 study [86].”
From New Developments in Pharmacological Treatment of Obesity and Type 2 Diabetes—Beyond and within GLP-1 Receptor Agonists (2024) · cites this paper as [86]
Tirzepatide's dual agonism (activating both GLP-1 and GIP receptors) may offer superior efficacy compared to single-agonist GLP-1 therapies.
“These trials also included older adults, showing that tirzepatide’s dual agonism (activating both GLP-1 and GIP receptors) may offer superior efficacy compared to single-agonist GLP-1 therapies.”
From A Narrative Review on GLP-1 Receptor Agonists for Obesity in Older Women: Maximizing Weight Loss While Preserving Lean Mass (2026) · cites this paper as [41]
Tirzepatide's sustained effects were confirmed up to 72 weeks.
“The sustained effects of tirzepatide were confirmed up to 72 weeks, highlighting its potential for long-term use in older adults managing obesity.”
From A Narrative Review on GLP-1 Receptor Agonists for Obesity in Older Women: Maximizing Weight Loss While Preserving Lean Mass (2026) · cites this paper as [41]
Tirzepatide improves weight and HbA1c in people with type 2 diabetes and obesity.
“SURMOUNT-2 (obesity + T2D) confirmed 14.7% mean Weight loss at 15 mg over 72 weeks [31]. HbA1c reduction − 2.08%, with 84% of participants achieving HbA1c < 7.0%, and 49% HbA1c < 5.7%.”
From Precision obesity medicine: A phenotype-guided framework for pharmacologic therapy across the lifespan (2025) · cites this paper as [31]
Heterogeneity in response to GLP-1 receptor agonist weight loss exists.
“Although most patients taking a GLP-1 RA achieve clinically meaningful weight loss, heterogeneity in response exists.3,4,5,6,7,12”
From Discontinuation and Reinitiation of Dual-Labeled GLP-1 Receptor Agonists Among US Adults With Overweight or Obesity (2025) · cites this paper as [4]
GLP-1 receptor agonists substantially lower weight, hemoglobin A1c levels, and cardiovascular risk.
“Although glucagon-like peptide-1 receptor agonists (GLP-1 RAs) substantially lower weight,3,4,5,6,7 hemoglobin A1c levels, and cardiovascular risk,8 trials suggest they must be continued for sustained effects.9,10”
From Discontinuation and Reinitiation of Dual-Labeled GLP-1 Receptor Agonists Among US Adults With Overweight or Obesity (2025) · cites this paper as [4]
The intervention duration ranged from 24 to 28 weeks in five trials and from 30 to 56 weeks in 21 trials; two trials had durations of 72 and 104 weeks.
“The intervention duration ranged from 24 to 28 weeks in five trials and from 30 to 56 weeks in 21 trials. The remaining two trials, a trial with tirzepatide in people with obesity and type 2 diabetes (SURMOUNT-2) [50] and a cardiovascular outcomes trial with semaglutide (SUSTAIN 6) [31], had a duration of 72 and 104 weeks, respectively.”
Considering the prominent role of adipose tissue in energy homeostasis, it is plausible that GIPR agonism in fat could harness beneficial effects on metabolic homeostasis.
“Considering the prominent role of adipose tissue in energy homeostasis59,172, it is plausible that GIPR agonism in fat could harness beneficial effects on metabolic homeostasis.”
From Transforming obesity: The advancement of multi-receptor drugs (2024) · cites this paper as [172]
The citation is attached to the statement about adipose tissue’s role in energy homeostasis, rather than to the citing authors’ subsequent speculation. The Introduction (page not available) discusses obesity and metabolic effects of GIP and GLP-1, and the Discussion (page not available) considers possible mechanisms of tirzepatide, but neither addresses adipose tissue’s role in energy homeostasis. Searches for adipose tissue and fat did not find a passage establishing that point. (LLM, conf=0.72)
Experimental — accuracy not yet measuredThe magnitude of weight loss with retatrutide exceeded that seen with other pipeline multi-agonists such as CagriSema, mazdutide and survodutide.
“Moreover, the magnitude of WL with retatrutide also exceeded that seen with other pipeline multi-agonists such as CagriSema (cagrilintide, an amylin agonist, in combination with semaglutide), mazdutide and survodutide (Fig. 4) [8, 27, 35, 36, 45, 46, 49–53].”
From Triple Agonism Based Therapies for Obesity (2025) · cites this paper as [50]
The Discussion passages (page unavailable) compare tirzepatide with other treatments, not retatrutide with CagriSema, mazdutide, or survodutide. Searches for retatrutide and those named multi-agonists found no passage in our copy addressing the claimed comparison. (LLM, conf=0.76)
Experimental — accuracy not yet measuredSGLT2 inhibitors improve HFpEF outcomes, but have variable and modest effects on health status and exercise function, with resultant significant residual risk.
“Sodium-glucose cotransporter-2 (SGLT2) inhibitors improve HFpEF outcomes, 13,14 but have variable and modest effects on health status and exercise function, with resultant significant residual risk. 15-17”
From Semaglutide versus placebo in people with obesity-related heart failure with preserved ejection fraction: a pooled analysis of the STEP-HFpEF and STEP-HFpEF DM randomised trials (2024) · cites this paper as [17]
The cited paper’s Discussion concerns SURMOUNT-2 participants with obesity and type 2 diabetes, while its supplementary efficacy results compare tirzepatide with placebo. Searches for SGLT2 inhibitors, HFpEF, exercise function, and residual risk found no passage addressing their effects in HFpEF. (LLM, conf=0.76)
Experimental — accuracy not yet measuredAt least 5 trials (including the present study) across various classes of medications, including potent antiobesity medications such as semaglutide, have demonstrated that weight is substantially regained after cessation of pharmacotherapy.
“At least 5 trials (including the present study) across various classes of medications, including potent antiobesity medications such as semaglutide, have demonstrated that weight is substantially regained after cessation of pharmacotherapy.5,6,23,24”
From Continued Treatment With Tirzepatide for Maintenance of Weight Reduction in Adults With Obesity: The SURMOUNT-4 Randomized Clinical Trial (2024) · cites this paper as [24]
The Discussion compares weight loss during active treatment with tirzepatide, semaglutide, and liraglutide; it does not report weight regain after stopping them. The week-72 results likewise concern treatment outcomes, not post-cessation weight. Searches for weight regain after cessation and withdrawal found no passage establishing the claimed finding or the count of at least five trials. (LLM, conf=0.75)
Experimental — accuracy not yet measuredWeight loss was less (14.7% in SURMOUNT-2) for overweight and obese individuals with type 2 diabetes than in those without type 2 diabetes.
“Weight loss was less (14.7% in SURMOUNT-2) for overweight and obese individuals with T2DM [33].”
From Recent advances in peptide-based therapies for obesity and type 2 diabetes (2024) · cites this paper as [33]
Liraglutide, semaglutide, and tirzepatide have demonstrated substantial and clinically meaningful weight loss in adults with obesity across multiple randomized controlled trials.
“Liraglutide, semaglutide, and tirzepatide have demonstrated substantial and clinically meaningful WL in adults with obesity across multiple RCTs.”
From Nutrition and Physical Activity in Optimizing Weight Loss and Lean Mass Preservation in the Incretin-Based Medications Era: A Narrative Review (2025) · cites this paper as [19]
Semaglutide 2.4 mg weekly, evaluated in the STEP program, consistently produced 14.9-17.4% weight loss.
“Semaglutide 2.4 mg weekly, evaluated in the STEP program, consistently produced 14.9–17.4% WL [19]”
From Nutrition and Physical Activity in Optimizing Weight Loss and Lean Mass Preservation in the Incretin-Based Medications Era: A Narrative Review (2025) · cites this paper as [19]
Nutrient-stimulated hormone-based therapies are the most efficacious anti-obesity medications currently available.
“They are the most efficacious AOMs currently available (Figure 1).[61][62][63][64]”
From Approach to Obesity Treatment in Primary Care: A Review (2024) · cites this paper as [63]
At tirzepatide 15 mg group, 52% of participants achieved ≥15% WL compared to 2.6% at placebo group.
“At the tirzepatide 15 mg group, 52% of participants achieved ≥ 15% WL compared to 2.6% at the placebo group [53].”
In SURMOUNT-2, tirzepatide 10 and 15 mg once weekly combined with a moderate intensity lifestyle intervention led to a mean HbA1c reduction of up to −2.1%, with 84-87% of participants achieving HbA1c ≤6.5%.
“In people with obesity and T2D (SURMOUNT-2 trial), tirzepatide 10 and 15 mg once weekly combined with a moderate intensity lifestyle intervention led to a mean HbA1c reduction of up to −2.1%, with 84–87% of the participants achieving HbA1c ≤ 6.5% [53].”
Placebo-adjusted discontinuation rates due to nausea were <6%.
“Placeboadjusted discontinuation rates due to nausea were <6% [12,36,52,68,70,94,103].”
From Symptomatic Adverse Events and Quality of Life Related to Incretin-Based Medicines for Obesity: A Systematic Review Involving >400,000 Subjects (2025) · cites this paper as [52]
Placebo-adjusted discontinuation due to diarrhea was ≤2% in all publications that reported the AE.
“Placebo-adjusted discontinuation due to diarrhea was ≤2% in all publications that reported the AE [12,36,52,70,94,103].”
From Symptomatic Adverse Events and Quality of Life Related to Incretin-Based Medicines for Obesity: A Systematic Review Involving >400,000 Subjects (2025) · cites this paper as [52]
Gastrointestinal serious AEs were reported in nine publications including the SCALE, STEP, and SURMOUNT clinical studies.
“Gastrointestinal serious AEs (SAEs) were reported in nine publications [12,36,52,81,85,89,94,98,103] including the SCALE (liraglutide), STEP (semaglutide), and SURMOUNT (tirzepatide) clinical studies.”
From Symptomatic Adverse Events and Quality of Life Related to Incretin-Based Medicines for Obesity: A Systematic Review Involving >400,000 Subjects (2025) · cites this paper as [52]
Diarrhea occurred at higher incidence with IBTs than placebo and was typically mild or moderate, transient, and occurred during the dose-escalation phase.
“Diarrhea (56 publications) occurred at higher incidence with IBTs than placebo and was typically mild or moderate (where severity was reported) [12,36,52,70,94,103], transient, and occurred during the dose-escalation phase (where timing was reported) [12,94,103] (Table S6).”
From Symptomatic Adverse Events and Quality of Life Related to Incretin-Based Medicines for Obesity: A Systematic Review Involving >400,000 Subjects (2025) · cites this paper as [52]
Placebo-adjusted discontinuation due to vomiting AEs was reported by five publications and ranged from 0 to 2.1%.
“Placebo-adjusted discontinuation due to vomiting AEs was reported by five publications [12,36,52,94,103] and ranged from 0 to 2.1%.”
From Symptomatic Adverse Events and Quality of Life Related to Incretin-Based Medicines for Obesity: A Systematic Review Involving >400,000 Subjects (2025) · cites this paper as [52]
Nineteen publications reported gallstones or gallbladder-related disorders in 0-3.1% of patients treated with liraglutide, 0.2-7% with semaglutide, and 0-2.9% with tirzepatide.
“Nineteen publications reported gallstones or gallbladder-related disorders [11-14,30,36,40,52,62,65,74,77,78,84,85,93,94,103] in 0-3.1%, 0.2-7%, 0-2.9% of patients treated with liraglutide, semaglutide, and tirzepatide, respectively.”
From Symptomatic Adverse Events and Quality of Life Related to Incretin-Based Medicines for Obesity: A Systematic Review Involving >400,000 Subjects (2025) · cites this paper as [52]
In the SURMOUNT clinical trials (tirzepatide), AEs were also most frequent during the dose-escalation phase (first 20 weeks), with the proportion of patients experiencing AEs decreasing up to the trial endpoint.
“In the SURMOUNT clinical trials (tirzepatide), AEs were also most frequent during the dose-escalation phase (first 20 weeks), with the proportion of patients experiencing AEs decreasing up to the trial endpoint [12,36,52,94,103].”
From Symptomatic Adverse Events and Quality of Life Related to Incretin-Based Medicines for Obesity: A Systematic Review Involving >400,000 Subjects (2025) · cites this paper as [52]
GLP-1RA efficacy is lessened in participants with a lower starting weight/BMI or with prior exposure to GLP-1RAs, and it is reduced by a third in type 2 diabetics and in male individuals.
“Notably, GLP-1RA efficacy is lessened in participants with a lower starting weight/BMI or with prior exposure to GLP-1RAs (95, 102), and it is reduced by a third in type 2 diabetics and in male individuals (79, 93, 95‐97, 99).”
From GLP-1 and the Neurobiology of Eating Control: Recent Advances (2025) · cites this paper as [99]
One mechanism for tuning circuit activation within brainstem GLP-1R neuron populations is thought to contribute to clinical observations that tirzepatide elicits fewer discontinuation-inducing adverse gastrointestinal events than semaglutide, likely in part due to GIPR-expressing GABAergic area postrema neurons inhibiting area postrema and/or nucleus tractus solitarius neurocircuits which mediate
“One such mechanism for tuning circuit activation within brainstem GLP-1R neuron populations is thought to contribute to clinical observations that the GLP-1R/GIPR co-agonist tirzepatide elicits fewer discontinuation-inducing adverse gastrointestinal events than semaglutide (98, 99), likely in part due to GIPR-expressing GABAergic AP neurons inhibiting AP and/or NTS neurocircuits which mediate GLP-”
From GLP-1 and the Neurobiology of Eating Control: Recent Advances (2025) · cites this paper as [99]
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“Weight loss was slightly lower, at 14.7%, in overweight and obese patients with T2DM in the SURMOUNT-2 study [86].”
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“In SURMOUNT 2, 938 participants with type 2 diabetes were randomly assigned to tirzepatide 10 mg ( n = 312), tirzepatide 15 mg ( n = 311), or placebo ( n = 315) [83].”
GLP-1 and the Neurobiology of Eating Control: Recent Advances
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“Similarly, the SURMOUNT-1 [40] and 2 [41] trials, which evaluated the effects of tirzepatide, revealed even greater weight loss efficacy, with mean reductions in body weight ranging from 15% to 21%.”
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- Authors
- Garvey, W. T., Frias, J. P., Jastreboff, A. M., le Roux, C. W., Sattar, N., Aizenberg, D., Mao, H., Zhang, S., Ahmad, N. N., Bunck, M. C., Benabbad, I., Zhang, X. M., Abalos, F. H., Manghi, F. C. P., Zaidman, C. J., Vico, M. L., Aizenberg, D., Costanzo, P. R., Serra, L. P., MacKinnon, I. J., Hissa, M. N., Vidotti, M. H., Kerr Saraiva, J. F., Alves, B. B., Franco, D. R., Moratto, O., Murthy, S., Goyal, G., Yamasaki, Y., Sato, N., Inoue, S., Asakura, T., Shestakova, M., Khaykina, E., Troshina, E., Vorokhobina, N., Ametov, A., Tu, S.-T., Yang, C.-Y., Lee, I.-T., Huang, C.-N., Ou, H.-Y., Freeman, G., Machineni, S., Klein, K., Sultan, S., Parsa, A., Otero-Martinez, J., Gonzalez, A., Bhargava, A., Brian, S., Ince, C., Plantholt, S., Cole, J., Lacour, A., Vega, D., de Souza, J., Rohlf, J. L., St. John, R. C., Horowitz, B., Audish, H., Galindo, R., Umpiperrez, G., Ard, J., Curtis, B., Garvey, W. T., Fraser, N. J., Mandry, J., Mohseni, R., Mayfield, R., Powell, T., Vance, C., Ong, S., Lewy-Alterbaum, A. L., Murray, A., Al-Karadsheh, A., Yacoub, T., Roberts, K., Fried, D. L., Rosenstock, J., Pulla, B., Bode, B., Frias, J., Klaff, L., Brazg, R., Van, J., Tan, A., Briskin, T., Rhee, M., Chaicha-Brom, T., Hartley, P. A., Nunez, L., Cortes-Maisonet, G., Soucie, G., Hsia, S., & Jones, T.
- Affiliations
- Velocity Clinical Research (United States) (US)
- Yale University (US)
- University of Glasgow (GB)
- Eli Lilly (United States) (US)
- University College Dublin (IE)
- ORCID
- Jastreboff, Ania M
- Sattar, Naveed
- Zhang, Shuyu
- Bunck, Mathijs C
- Franco, Denise R.
- Murthy, Sreenivasa
- Sato, Nobuyuki
- Shestakova, Marina
- Troshina, Ekaterina
- Tu, Shih-Te
- Yang, Chwen-Yi
- Lee, I-Te
- Huang, Chien-Ning
- Ou, Horng-Yih
- Klein, Klara
- Parsa, Alan
- Gonzalez, Alex
- Bhargava, Anuj
- Horowitz, Barry
- Galindo, Rodolfo
- Ard, Jamy
- Rosenstock, Julio
- Bode, Bruce
- Van, Joanna
- Hsia, Stanley
- Venue
- The Lancet
- Publisher
- Elsevier BV
- Published
- 2023-08
- Volume
- 402
- Issue
- 10402
- Pages
- 613-626
- ISSN
- 0099-5355 (ISSN-L)
- 0140-6736
- OpenAlex
- W4382050932
- Semantic Scholar
- 8d18123eb88ecfb6be97e7ef16bda08f764a78c7
- Cited by
- 792
- References
- 35
- Citations by year
- 2026: 239 · 2025: 286 · 2024: 221 · 2023: 46
- FWCI
- 122.35
- Type
- journal article
- Language
- en
- Open access
- green
- pure.ulster.ac.uk
- Licence
- Locations
- The Lancet (publishedVersion)
- PubMed (publishedVersion)
- Ulster University Research Portal (Ulster University) (submittedVersion, other-oa)
- Funders
- Eli Lilly and Company
- Topics
- Health Sciences › Medicine › Pharmacology › Pharmacology and Obesity Treatment
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Epidemiology › Adipokines, Inflammation, and Metabolic Diseases
- Keywords
- tirzepatide, obesity, type 2 diabetes, weight loss, GLP-1 receptor agonists, GIP receptor agonist, glucose-dependent insulinotropic polypeptide, HbA1c, adverse events, drug safety, treatment discontinuation
- MeSH terms
- Tirzepatide, Adolescent, Adult, Body Weight, Diabetes Mellitus, Type 2, Double-Blind Method, Glucagon-Like Peptides, Female, Humans, Hypoglycemic Agents, Male, Middle Aged, Obesity, Treatment Outcome
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